Cerebral PalsyNCT00352326
Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity
A study testing reprogramming assisted communication device interface in people with Cerebral Palsy, run by University of Southern California at 1 site in United States.
Trial summary
For children who depend on devices to communicate, the rate of communication is a primary determinant of success. For children with motor impairments, the rate of communication may be limited by inability to contact buttons or cells rapidly or accurately. Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- reprogramming assisted communication device interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria:- Use of Dynavox ability to follow two-step commands impairment in arm function Exclusion Criteria:- increased risks of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
For children who depend on devices to communicate, the rate of communication is a primary determinant of success. For children with motor impairments, the rate of communication may be limited by inability to contact buttons or cells rapidly or accurately. It is therefore essential to know how to adjust the device interface in order to maximize each child's rate of communication. The optimal rate of communication is determined by the Channel Capacity, which is the maximum value of the Information Rate for all possible keyboard button or cell layouts for the communication device. We construct a mathematical model for the information rate based on the relationship between movement time and the number of buttons per screen, the size of the buttons, and the length of a sequence of buttons that must be pressed to communicate each word in the vocabulary. We measure the parameters of the model using a custom-programmed touch-screen interface.
- Conditions
- Cerebral Palsy
- Being tested
- reprogramming assisted communication device interface
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reprogramming assisted communication device interfaceDevice
The subjects were required to touch targets on the iPad® screen with the index finger of their preferred (less-affected) arm. The experimental task consisted of 180 targets divided in 4 blocks: 45 targets each block with a 1-minute interval between trials to avoid fatigue. Targets appeared at 1 of 9 different locations on the screen, and subjects moved their finger sequentially from one target to the next.
| Study group | Role | What they receive |
|---|---|---|
| Children (with dystonia and controls) | Experimental | Participants sat in a chair or their own wheelchair in front of a table whose surface height was adjusted at the midpoint between the hip and the Xiphoid process. They placed the hand that was not used for the task on their lap.
An iPad® (Apple Inc, Cupertino, California) was located on the table in portrait mode in front of the participants at a distance that ranged between 40 and 55 cm. An adjustable metal bookstand supported the iPad® to allow the participants a comfortable screen view. The size of the screen was 19.5 × 14.6 cm. Custom software was developed for the experimental task (XCode 3.2 development environment, iOS 4.2 operating system; Apple Inc, Cupertino, California). Receives: Device: reprogramming assisted communication device interface |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terence Sanger, University of Southern California
- Investigators
- Terence D. Sanger, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352326
- Sponsor's protocol ID
- FITTS PILOT
- Status last verified
- May 2017
- First submitted
- 12 Jul 2006
- Last updated
- 19 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity
- ClinicalTrials.gov ID
- NCT00352326
- Acronym / sponsor ID
- FITTS PILOT
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For children who depend on devices to communicate, the rate of communication is a primary determinant of success. For children with motor impairments, the rate of communication may be limited by inability to contact buttons or cells rapidly or accurately. It is therefore essential to know how to adjust the device interface in order to maximize each child's rate of communication. The optimal rate of communication is determined by the Channel Capacity, which is the maximum value of the Information Rate for all possible keyboard button or cell layouts for the communication device. We construct a mathematical model for the information rate based on the relationship between movement time and the number of buttons per screen, the size of the buttons, and the length of a sequence of buttons that must be pressed to communicate each word in the vocabulary. We measure the parameters of the model using a custom-programmed touch-screen interface.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children (with dystonia and controls) | Experimental | Device: reprogramming assisted communication device interfaceParticipants sat in a chair or their own wheelchair in front of a table whose surface height was adjusted at the midpoint between the hip and the Xiphoid process. They placed the hand that was not used for the task on their lap. An iPad® (Apple Inc, Cupertino, California) was located on the table in portrait mode in front of the participants at a distance that ranged between 40 and 55 cm. An adjustable metal bookstand supported the iPad® to allow the participants a comfortable screen view. The size of the screen was 19.5 × 14.6 cm. Custom software was developed for the experimental task (XCode 3.2 development environment, iOS 4.2 operating system; Apple Inc, Cupertino, California). |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reprogramming assisted communication device interfaceThe subjects were required to touch targets on the iPad® screen with the index finger of their preferred (less-affected) arm. The experimental task consisted of 180 targets divided in 4 blocks: 45 targets each block with a 1-minute interval between trials to avoid fatigue. Targets appeared at 1 of 9 different locations on the screen, and subjects moved their finger sequentially from one target to the next. | Device | Children (with dystonia and controls) |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terence D. Sanger principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reprogramming assisted communication device interface in people with Cerebral Palsy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.